Orapred ODT Arrives in U.S. Market
ALPHARETTA, Ga., Aug. 28 /PRNewswire/ — The first orally disintegrating tablet form of prednisolone available in the United States reaches pharmacies this month. Orapred ODT(TM) (prednisolone sodium phosphate orally disintegrating tablets) is marketed in the United States by Alliant Pharmaceuticals, pursuant to a licensing and acquisition agreement entered into with BioMarin Pharmaceutical Inc. . The U.S. Food and Drug Administration granted marketing approval of the drug in June.
Orapred ODT is expected to be prescribed primarily for acute exacerbations of asthma in children. Orapred ODT is also used to control severe, persistent asthma and to reduce inflammation seen in numerous medical conditions including arthritis and cancer. Orapred ODT utilizes a proprietary orally disintegrating tablet technology to provide a taste-masked, non-refrigerated and convenient formulation of prednisolone. As with all glucocorticoids, Orapred ODT is contraindicated in persons with systemic fungal infections. In clinical trials of Orapred ODT, the following adverse events ere seen: facial edema, pharyngolaryngeal pain, blood in stool, eye irritation, and eyelid edema.
“We are excited to bring physicians another option for dispensing prednisolone,” said Mark Pugh, Chief Executive Officer of Alliant Pharmaceuticals. “Patient compliance is always an important issue.”
In a study published in the June 2006 issue of Pediatric Emergency Care, Orapred oral solution was shown to have an advantage over its generic competitors. Study results showed that among the 211 study participants with severe asthma exacerbation, there was a taste preference towards Orapred over the generic formulation, and children taking the generic formulation experienced a 17.7 percent increase in vomiting compared to those who took Orapred oral solution.
“An unpalatable taste may be a frequent cause of noncompliance in children,” adds Pugh. “Orapred was formulated with the young child with asthma in mind. The study showed we were successful in creating a product that children found palatable. And with Orapred ODT, the options have now increased.”
About Alliant Pharmaceuticals, Inc.
Alliant Pharmaceuticals, Inc. is a Specialty Pharmaceutical company formed to develop and market a portfolio of innovative pharmaceutical products to pediatricians and pediatric specialty physicians. Alliant Pharmaceuticals focuses on identifying opportunities to acquire and enhance the market potential of innovative, commercially available therapeutics and late-stage development drugs to fulfill unmet medical needs. Additional information about Alliant Pharmaceuticals in available online at: http://www.alliantpharma.com/.
Contact: Sharon Kraun, 770.804.2594
skraun@bellsouth.net
Alliant Pharmaceuticals, Inc.
CONTACT: Sharon Kraun, +1-770-804-2594, skraun@bellsouth.net for AlliantPharmaceuticals, Inc.
Web site: http://www.alliantpharma.com/